Trial Outcomes & Findings for Copper IUD Treatment Observation Study (NCT NCT02519231)
NCT ID: NCT02519231
Last Updated: 2020-10-14
Results Overview
Number of bleeding and spotting, spotting only and bleeding only days given as mean. We calculated the mean difference and 95% confidence interval between the two treatment groups and provided the p-value of means.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
4 months
Results posted on
2020-10-14
Participant Flow
Between February 2016 to May 2017, 34 women enrolled into the study, of whom 28 were randomized.
Subjects who completed the baseline questionnaires were contacted 4-5 weeks later to determine eligibility for randomization to a treatment arm. Participants were eligible to be randomized if they reported any change in menstrual bleeding since their TuC380A insertion, were willing to forgo NSAIDs, and willing to record their daily bleeding.
Participant milestones
| Measure |
Treatment
This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial .
Naproxen: Naproxen 440mg 1x bid for fist 7 days of menstrual cycle
|
Placebo
This study arm includes capsules that are exactly like the active treatment medication (naproxen), but there is no active treatment medication in these tablets.
Placebo: Placebo tablet 440mg 1x bid for first 7 days of menstruation
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Treatment
This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial .
Naproxen: Naproxen 440mg 1x bid for fist 7 days of menstrual cycle
|
Placebo
This study arm includes capsules that are exactly like the active treatment medication (naproxen), but there is no active treatment medication in these tablets.
Placebo: Placebo tablet 440mg 1x bid for first 7 days of menstruation
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Copper IUD Treatment Observation Study
Baseline characteristics by cohort
| Measure |
Treatment
n=14 Participants
This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial testing additional promising treatments, such as tranexamic acid.
Naproxen: Naproxen 440mg 1x bid
|
Placebo
n=14 Participants
This study arm includes capsules that are exactly like the active treatment medication (naproxen), but there is no active treatment medication in these tablets.
Placebo: Placebo tablet 1x bid
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
29.3 years
n=93 Participants
|
29.3 years
n=4 Participants
|
29.3 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
14 participants
n=4 Participants
|
28 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Population who submitted bleeding diaries at the end of the 6-month trial. We used intention-to-treat and included all data we had. We excluded missing data
Number of bleeding and spotting, spotting only and bleeding only days given as mean. We calculated the mean difference and 95% confidence interval between the two treatment groups and provided the p-value of means.
Outcome measures
| Measure |
Treatment
n=12 Participants
This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial .
Naproxen: Naproxen 440mg 1x bid for fist 7 days of menstrual cycle
|
Placebo
n=8 Participants
This study arm includes capsules that are exactly like the active treatment medication (naproxen), but there is no active treatment medication in these tablets.
Placebo: Placebo tablet 440mg 1x bid for first 7 days of menstruation
|
|---|---|---|
|
Mean Days of Bleeding and Spotting, Spotting Only and Bleeding Only for the 84 Day Treatment Cycles and Last 28 Day Post-treatment Cycle
Bleeding or spotting days first 84 days
|
29.2 days
Standard Error 4.5
|
23.0 days
Standard Error 2.8
|
|
Mean Days of Bleeding and Spotting, Spotting Only and Bleeding Only for the 84 Day Treatment Cycles and Last 28 Day Post-treatment Cycle
Bleeding or spotting days last 28 days
|
9.3 days
Standard Error 1.9
|
9.6 days
Standard Error 0.9
|
|
Mean Days of Bleeding and Spotting, Spotting Only and Bleeding Only for the 84 Day Treatment Cycles and Last 28 Day Post-treatment Cycle
Bleeding only days first 84 days
|
15.7 days
Standard Error 2.1
|
15.5 days
Standard Error 1.8
|
|
Mean Days of Bleeding and Spotting, Spotting Only and Bleeding Only for the 84 Day Treatment Cycles and Last 28 Day Post-treatment Cycle
Bleeding only days last 28 days
|
4.8 days
Standard Error 1.0
|
6.6 days
Standard Error 1.2
|
|
Mean Days of Bleeding and Spotting, Spotting Only and Bleeding Only for the 84 Day Treatment Cycles and Last 28 Day Post-treatment Cycle
Spotting only days first 84 days
|
13.5 days
Standard Error 5.1
|
7.5 days
Standard Error 1.7
|
|
Mean Days of Bleeding and Spotting, Spotting Only and Bleeding Only for the 84 Day Treatment Cycles and Last 28 Day Post-treatment Cycle
Spotting only days last 28 days
|
4.5 days
Standard Error 2.0
|
3.0 days
Standard Error 0.8
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Includes participants who responded to the monthly questionnaires, based on intention to treat analysis.
Percentage reporting moderate-heavy/heavy menses, often/always menstrual cramping and 7 or more days of menstrual bleeding during the first 84 days and the last 28 days. We also report % difference and p-value between the two treatment groups.
Outcome measures
| Measure |
Treatment
n=13 Participants
This study arm includes naproxen as potential treatment for heavy or prolonged bleeding or dysmenorrhea may provide useful preliminary data for a larger, adequately powered placebo-controlled comparative trial .
Naproxen: Naproxen 440mg 1x bid for fist 7 days of menstrual cycle
|
Placebo
n=14 Participants
This study arm includes capsules that are exactly like the active treatment medication (naproxen), but there is no active treatment medication in these tablets.
Placebo: Placebo tablet 440mg 1x bid for first 7 days of menstruation
|
|---|---|---|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 1 : Unexpected bleeding
|
6 Participants
|
5 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 2 : Moderate heavy or heavy bleeding
|
4 Participants
|
8 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 3 : Moderate heavy or heavy bleeding
|
6 Participants
|
7 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 3 : Menstrual bleeding length 7+ days
|
6 Participants
|
5 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 4 : Moderate heavy or heavy bleeding
|
7 Participants
|
5 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 4 : Menstrual bleeding length 7+ days
|
6 Participants
|
6 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 4 : Often/always cramping
|
3 Participants
|
1 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 4 : Unexpected bleeding
|
5 Participants
|
6 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 1 : Moderate heavy or heavy bleeding
|
7 Participants
|
7 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 1 : Menstrual bleeding length 7+ days
|
8 Participants
|
5 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 1 : Often/always cramping
|
1 Participants
|
5 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 2 : Menstrual bleeding length 7+ days
|
8 Participants
|
5 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 2 : Often/always cramping
|
1 Participants
|
1 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 2 : Unexpected bleeding
|
7 Participants
|
7 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 3 : Often/always cramping
|
1 Participants
|
1 Participants
|
|
Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
Month 3 : Unexpected bleeding
|
1 Participants
|
5 Participants
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. If requested in writing, Institution and Investigator will withhold such Public Presentation for up to an additional ninety (90) days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER